safety, pharmacokinetics, and pharmacodynamics of mk-8876 in participants with hepatitis c infection (mk-8876-003)

Conditions: Hepatitis C

Summary: this adaptive design study will evaluate the safety, pharmacokinetics, and effect on hepatitis c virus (hcv) rna levels of multiple doses of mk-8876 in participants with hcv infection. the study will consist of 4 parts evaluating participants infected with specific hepatitis c virus genotypes and up to 10 panels allowing for additional participants to enroll in each panel as specified in the study analysis. the hypothesis evaluated in the study is that a ≥2.5 log iu/ml reduction in hcv rna from baseline will accompany multiple dose administration of mk-8876 in participants with hcv infection.


Eligibility criteria:
inclusion criteria: * is male, or female of non-childbearing potential (non-childbearing potential is defined as postmenopausal without menses for ≥1 year or after medically documented hysterectomy, oophorectomy, or tubal ligation) * agrees to use a medically acceptable method of contraception through 90 days after the last dose of study drug if participant has a female partner of childbearing potential must (males should use a condom and their partner of childbearing potential must use hormonal contraception, intrauterine device, diaphragm, cervical cap, or female condom) * has a body mass index (bmi) between 18 and 37 kg/m\^2 * has a clinical diagnosis of chronic hcv infection defined by positive serology for hcv for ≥6 months * agrees to follow the smoking and other trial restrictions exclusion criteria: * is mentally or legally institutionalized or incapacitated, has significant emotional problems at study start or has clinically significant psychiatric disorder of the last 5 years * has a history of clinically significant endocrine, gastrointestinal (except hcv infection), cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases * has a history of stroke, chronic seizures, or major neurological disorder * has a history of cancer (except adequately treated non-melanomatous skin carcinoma, carcinoma in situ of the cervix, or other malignancies which have been successfully treated for ≥10 years * has a history of significant multiple and/or severe allergies or has had an anaphylactic reaction or significant intolerability to drugs or food * has a history of clinically significant hepatic disease, gilbert's disease, biliary tract disease, or human immunodeficiency virus * has had major surgery or donated or lost \>1 unit of blood within 4 weeks before the study * has participated in another investigational trial within 4 weeks before the study * is unable to refrain from or anticipates the use of any medication from 2 weeks before the study and throughout the study * consumes \>2 glasses of alcoholic beverages per day * consumes \>6 servings (1 serving is \~120 mg caffeine) of coffee, tea, cola, energy drinks, or other caffeinated beverages per day * is a regular user of any illicit drugs or history of drug abuse within 12 months of the study * has evidence or history of chronic hepatitis not caused by hcv (except acute non-hcv-related hepatitis that resolved \>6 months before the study) * has previously received treatment with another hcv non-nucleoside inhibitor (previous use of other hcv investigational therapies or marketed compounds is permitted if treatment ended ≥3 months before the study) * has clinical or laboratory evidence of advanced or decompensated liver disease